Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Topotecan Teva   
Auth. number : EU/1/09/552
Active substance : topotecan
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XX - Other antineoplastic agents
Chemical substance: L01XX17 - Topotecan
(See WHO ATC Index)
Indication: Topotecan monotherapy is indicated for the treatment of:
 patients with metastatic carcinoma of the ovary after failure of first line or subsequent therapy.
 patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.

Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.
Marketing Authorisation Holder: Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
23/09/2009 Centralised - Authorisation EMEA/H/C/1071 (2009)7416 of 21/09/2009
11/12/2009 Centralised - Notification EMEA/H/C/1071/N/1
Updated with Decision(2011)6230 of 26/08/2011
08/07/2010 Centralised - Variation EMEA/H/C/1071/IB/2
Updated with Decision(2011)6230 of 26/08/2011
11/02/2011 Centralised - Variation EMEA/H/C/1071/IB/3
Updated with Decision(2011)6230 of 26/08/2011
31/08/2011 Centralised - Variation (2011)6230 of 26/08/2011
05/06/2012 Centralised - Variation EMEA/H/C/1071/IAin/4
Updated with Decision(2012)7734 of 25/10/2012
29/10/2012 Centralised - Variation (2012)7734 of 25/10/2012
13/02/2013 Centralised - Notification EMEA/H/C/1071/N/5
Updated with Decision(2014)4279 of 19/06/2014
13/09/2013 Centralised - Notification EMEA/H/C/1071/N/6
Updated with Decision(2014)4279 of 19/06/2014
23/06/2014 Centralised - Renewal EMEA/H/C/1071/R/7 (2014)4279 of 19/06/2014
02/12/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1071/T/8 (2014)9278 of 28/11/2014
29/01/2015 Centralised - Variation EMEA/H/C/1071/IB/10